Prostate Cancer
Conditions
Brief summary
Primary Objective: To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \[⁶⁸Ga\]Ga-ELI421 injection in patients with prostate cancer. Secondary Objectives: To evaluate the biodistribution characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \[⁶⁸Ga\]Ga-ELI421 injection.
Interventions
DRUG[68Ga]Ga-ELI421 injection
Administration Protocol: A single rapid intravenous bolus injection of \[68Ga\]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eli Radiopharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures; 2. Aged ≥ 18 years; 3. In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 4. Patients with histopathologically and/or cytologically confirmed prostate cancer; 5. Has an indication for PSMA PET imaging; 6. No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results. 7. Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.
Exclusion criteria
1. Presence of comorbidities that may compromise subject safety or interfere with imaging results; 2. Concomitant medications that may compromise subject safety or interfere with imaging results; 3. Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results; 4. Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions; 5. Inability to complete PET imaging as required; 6. Any other conditions deemed inappropriate by the investigator for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) | Day1, Day2-3 | Any abnormality, medication, or treatment after dosing shall be documented as an adverse event and concomitant medication / non-pharmacological treatment. All adverse events shall be followed up until resolution, stabilization or remission of symptoms, or until abnormal laboratory values return to normal, baseline or a stable state, or until a reasonable explanation is obtained (e.g., loss to follow-up, death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion uptake value | Day1 | ROIs shall be delineated to calculate the percentage injected dose (%ID), mean standardized uptake value (SUVmean), and retention time of target organs/tissues at various scanning time points. |
| Absorbed dose | Day1 | Absorbed dose of target organs/tissues and total-body effective dose. |
| Diagnostic performance | Day1 | Diagnostic performance of \[⁶⁸Ga\]Ga-ELI421 for lesion detection compared with PSMA PET, including the number of lesions and diagnostic performance indicators such as accuracy, sensitivity, and specificity. |
Countries
China
Contacts
CONTACTXiaoli Lan
Outcome results
None listed